United States: How SUPPORT Will Affect Pharma Interactions With DEA

The opioid package President Donald Trump signed last week
garnered much attention. While it is largely directed at treatment
and prevention, it contains several momentous provisions for those
companies that manufacture, distribute or dispense opioid
medications. This article discusses a few of the more important
provisions that are anticipated to affect the pharmaceutical
industry in its interactions with the U.S. Drug Enforcement
Administration. In short, the act imposes new requirements on
wholesale distributors related to handling of controlled substances
and increases penalties for failing to comply with the act and,
interestingly, imposes quite significant analytical and reporting
hurdles on the Drug Enforcement Administration and, to a lesser
extent, the U.S. Department of Health and Human Services.

The act codifies the requirement to report suspicious
orders and increases the penalties for failure to do so.

First, HR6 codifies what had previously been simply a regulatory
requirement that manufacturers and distributors must report to the
DEA suspicious orders of controlled substances.1 It also
slightly broadens the definition of suspicious orders by defining a
"suspicious order" as one that may include "but is
not limited to" orders of unusual size, orders deviating
substantially from a normal pattern, or orders of unusual
frequency. The act mimics the current regulatory requirement that a
DEA registrant must design and operate a system to identify
suspicious orders, but now also requires that the system comply
with applicable federal and state privacy laws. The act also
requires that reports must be filed "upon discovering
suspicious orders" or a "series of [suspicious]
order," and that reports must be sent to both the DEA
administrator and the DEA division office where the registrant is
located or conducts business.

The DEA has expended vast resources investigating and charging
manufacturers, distributors and pharmacy chains with failing to
report suspicious orders, and has collected hundreds of millions of
dollars in settlements from errant companies. It is unclear how
impactful codifying the regulatory landscape will be, but one
laudable impact is the requirement that the DEA create a
centralized data base to collect — and presumably analyze and
report — suspicious order data from the country's
thousands of manufacturer and distributor registrants. The act
requires the attorney general to establish a centralized database
for collecting these reports from industry within one year. It also
requires the DEA to report to Congress on its progress in creating
the mandatory centralized database as well as an explanation of how
the DEA utilizes industry's suspicious order reports both
before and after the passage of the act.

Careful analysis and data mining of suspicious order reports
could potentially lead to more specific and accurate identification
of suspicious orders, which in turn will go a long way to reduce
the flow of drugs outside legitimate scientific and medical
channels. But it remains to be seen how and whether the DEA will be
able to successfully stand up a centralized suspicious order report
data base. Certainly one challenge will be that there is no
standardized template or communication mode for transmitting
suspicious orders. The DEA is expected to publish a notice and
petition for rule making regarding suspicious orders by February
2019. Assuming the DEA complies with this deadline, we can expect
to see more clarity around both the definition of suspicious
orders, and as a result of the act, a form reporting template as
well as communication requirements. This will be helpful to
industry.

More ominously, the new law increases the penalties for failing
to report suspicious opioid orders. The act provides increased
civil penalties of up to $100,000 and a criminal fine of up to
$500,000 for manufacturers and distributors who fail to report
suspicious orders, fail to maintain effective controls against
opioid diversion or fail to review ARCOS
information.2

The act requires the DEA to share Automated Reports and
Consolidated Orders System, or ARCOS, data with regulated industry
and state partners.

Manufacturers and distributors are required to report on a
monthly basis its acquisitions and dispositions of all controlled
substances in Schedules I and II (which include opioids). In
apparent response to intense criticism that the DEA has always had
in its possession data that would help industry understand the
volume of controlled substances being delivered to a pharmacy, the
act imposes significant new data sharing requirements on the DEA.
Specifically, the new law requires the DEA, within one year from
enactment, to publish on a quarterly basis the total number of
distributors from which a particular pharmacy buys and the total
quantity and type of opioids distributed to each pharmacy or
practitioner. This will finally allow manufacturers and
distributors to see the total volume a pharmacy gets from each
distributor, a critical piece of information to assess whether a
particular pharmacy is filling an unusual amount of prescriptions.
The provisions further mandate that the DEA share information with
regulatory, licensing, attorneys general and law enforcement
agencies of states on a semi-annual basis related to amounts,
outliers and trends of distributor and pharmacy registrants.

However, the improved data sharing does not come without a
price. The new law will punish a manufacturer or distributor who
does not review and assess the newly available data. In particular,
the law provides that all registered manufacturers and distributors
shall be responsible for reviewing the information made available
by the attorney general under this subsection and may be penalized
if the DEA can prove that drug manufacturers and distributors
failed to consider available ARCOS data when determining whether an
order for opioids is suspicious.

The act aims to empower pharmacists to refuse to fill
suspicious prescriptions.

In recent years, the DEA has focused significant attention on
the pharmacist's role in preventing diversion of controlled
substances. Regulations under the Controlled Substances Act provide
that while "the responsibility for the proper prescribing and
dispensing of controlled substances is upon the prescribing
practitioner ... a corresponding responsibility rests with the
pharmacist who fills the prescription."3 The DEA
has indicated through enforcement actions and informal guidance
that it interprets this obligation to mean that pharmacists have an
obligation to decline to fill suspicious prescriptions and, beyond
that, to ensure that no other pharmacists within a single store or
drugstore chain fill prescriptions for a suspicious patient or
practitioner. This is sometimes called a blanket refusal to fill.
Blanket refusals are controversial because many states have
regulations that require pharmacists to evaluate each and every
prescription individually. Additionally, certain state regulations
suggest that if a prescription appears facially valid and is
written by a duly licensed practitioner, a pharmacist is required
to fill it.

Ostensibly to breach this divide, Section 3212 of the act
directs the Department of Health and Human Services to help develop
and disseminate materials clarifying the circumstances under which
pharmacists may decline to fill controlled substance prescriptions,
such as when they suspect the prescriptions are fraudulent, forged
or of doubtful, questionable or suspicious origin.

There is no doubt that myriad and conflicting state and federal
obligations put pharmacists and the pharmacies that employ them in
a challenging position. But law enforcement priorities and the
opioid crisis have imposed an ever-increasing expectation on
pharmacists to act as a gatekeeper to stop individual suspicious
prescriptions but also to share that view widely within their
stores, chains and even communities. The act's requirement that
HHS educate pharmacists about their rights and responsibilities in
this area will hopefully lead to more clear guidance for
pharmacists that will empower them to fulfill the gatekeeper role
that they clearly play.

Footnotes

[1] See Act, Sec. 3292.

[2] See Sec. 3273(c).

[3] 21 C.F.R. § 1306.04.

Originally published by Law360.

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In a time where marijuana legalization is rapidly expanding, all employers should reassess their workplace drug testing policies to be sure they are in compliance with existing and soon to be effective state and local laws.

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